Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

A localised lymph node assay (LLNA) study was conducted by Huntingdon Life Sciences, UK, to determine the potential for skin sensitization of the test substance. The study was conducted according to OECD 429 and EEC B.42 Test Guidelines, and was performed in compliance with GLP. The test substance is regarded as a sensitizer if at least one concentration of the test substance results in a three-fold greater increase in 3HTdR incorporation compared to control values.

The test substance was found to generate a test/control ratio greater than 3 at two of the concentration tested (5 and 10% (w/v)), and so the test substance was considered to have the potential to cause skin sensitization (delayed contact hypersensitivity).


Migrated from Short description of key information:
The test substance was considered to have the potential to cause skin sensitisation (delayed contact hypersensitivity). The LLNA EC3 value was calculated to be 3.1% (w/v) (31 mg/mL) and the highest concentration administered which did not result in skin sensitization was 2.5% w/v.

Justification for classification or non-classification

A local lymph node assay (LLNA) was performed to assess the potential for skin sensitization of the test substance. The test substance showed the potential to induce skin sensitization. On the basis of the result, the test substance requires classification as GHS H317 “May cause an allergic skin reaction” and should be categorized as sub-category 1B (moderate skin sensitizer).